Migraine Clinical Trial
Official title:
Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Verified date | February 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.
Status | Completed |
Enrollment | 92 |
Est. completion date | February 23, 2023 |
Est. primary completion date | February 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion criteria: - Age = 21 and = 65 - Able to communicate in English - Migraine, with or without aura, in its episodic or chronic manifestations, as per the International Headache Society (IHS) classification International Classification of Headache Disorders (ICHD-3) criteria (section 1.1, 1.2, 1.3).(48) - Ability to provide informed consent and complete website questionnaires in English - Agrees not to use cannabis outside of the study during participation in the study - Agrees not to use opioids or barbiturates during participation in the study - Agrees not to drive a motor vehicle within 4 hours following last use of inhaled cannabis during participation in the study Exclusion Criteria: - Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment - Pregnancy - Breastfeeding - Prisoner - Known cognitive impairment - Institutionalized - Current moderate-severe or severe depression - Current or past history of bipolar depression, schizophrenia, or psychosis - Current or past history of cannabis, alcohol, opioid, or amphetamine abuse or other substance use disorder at the discretion of the research team - Active pulmonary disease class IV heart failure, cirrhosis, or other severe medical illnesses at the discretion of the research team. - Allergy or past adverse effects or negative past experiences from cannabis |
Country | Name | City | State |
---|---|---|---|
United States | Center for Pain Medicine, UC San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Migraine Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Headache pain relief | Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain | 1 hour, 24 hours, 48 hours | |
Other | Headache pain freedom | Dichotomous endpoint of reduction from moderate/severe pain to no pain | 1 hour, 24 hours, 48 hours | |
Other | Most bothersome symptom freedom | Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration | 1 hour, 24 hours, 48 hours | |
Other | Freedom from photophobia | Dichotomous endpoint of resolution of photophobia | 1 hour, 2 hours, 24 hours, 48 hours | |
Other | Freedom from phonophobia | Dichotomous endpoint of resolution of phonophobia | 1 hour, 2 hours, 24 hours, 48 hours | |
Other | Freedom from nausea | Dichotomous endpoint of resolution of nausea | 1 hour, 2 hours, 24 hours, 48 hours | |
Other | Freedom from vomiting | Dichotomous endpoint of whether patient vomited during this migraine attack | At any time over 48 hours | |
Other | Use of rescue medication | Dichotomous endpoint of use of rescue medication | At any time over 48 hours | |
Other | Sustained pain freedom | Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain | 24 hours and 48 hours | |
Other | Sustained most bothersome symptom freedom | Dichotomous endpoint of absence of most bothersome symptom at 2 hours afer dose, with no use of rescue medication and no relapse of most bothersome symptom | 24 hours and 48 hours | |
Primary | Headache Pain Relief at 2 Hours Post-Treatment | Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain | 2 Hours Post-Treatment | |
Secondary | Headache pain freedom | Dichotomous endpoint of reduction from moderate/severe pain to no pain | 2 hours | |
Secondary | Most bothersome symptom freedom | Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration | 2 hours |
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